Update 06/03/2022:
The next food facility registration renewal period begins October 1st and continues through December 31st. In preparation for this upcoming renewal season, FDA recently began validating the UFI status of existing registrations. The information listed on the facility registration must match exactly what is listed with Dun & Bradstreet. Any facility with a “PENDING” UFI or inconsistent company name or address information within the Dun & Bradstreet database risks cancellation of its facility registration if the information is not corrected by the end of the renewal season. FDA Issues Notices to Food Facilities with Inadequate UFI Status.
Original Post, 02/08/ 2022:
In March of 2020, the US Congress and President Trump signed into law the Coronavirus Aid, Relief, and Economic Security (CARES) Act to help mitigate the economic and health consequences caused by the COVID-19 pandemic. One requisite of the CARES Act was to heighten the reporting requirements for medical device, drug, and active pharmaceutical ingredient (APIs) manufacturers. Now in 2022, there is a new requirement that calls for most drug manufacturers to create a yearly report of the annual manufacturing volume of drug products to the Food and Drug Administration (FDA).
In October of 2021, FDA published a guidance document for implementing this new requirement, outlining the procedures for reporting through their new online portal, FDA CDER NextGen. FDA requires the manufacturing volumes produced during 2020 and 2021 to be reported. The Agency requests all reporting for the calendar year 2020 be completed by February 15, 2022, and calendar year 2021 be completed by May 16, 2022. Moving forward, submission of this report will be an annual requirement, reporting the preceding year’s production by February 15 of the following year.
This new annual reporting is required for manufacturers and/or private label distributors who processed, labeled, manufactured or prepared listed drug products for the United States market. Examples of the items that must be reported include:
- Finished dosage form products
- APIs
- Over-the-counter (OTC) drugs
- Homeopathic drugs
- Animal drugs
- Drug kits
- and more…
It is important to note that FDA does acknowledge that exemptions may apply to certain biological products.
FDAImports has a long history of efficiently and successfully navigating FDA’s requirements and systems. If you need assistance with submitting your reports or have questions about your drug product(s) regulations, please contact us today for help.
